Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2024-12-18

Brief Summary

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The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.

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Detailed Description

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All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

Conditions

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Pancreatic Diseases Pancreas Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural analgesia

Group Type ACTIVE_COMPARATOR

Analgesia via epidural catheter

Intervention Type PROCEDURE

Ropivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Wound catheter analgesia

Group Type EXPERIMENTAL

Analgesia via wound catheter

Intervention Type PROCEDURE

Ropivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Interventions

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Analgesia via epidural catheter

Ropivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Intervention Type PROCEDURE

Analgesia via wound catheter

Ropivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 18 years or over
* patients who undergo pancreaticoduodenectomy

Exclusion Criteria

* patients to whom are made a major vascular reconstruction
* patients with significant comorbidities and inability to use PCA
* regural use of strong opioids or drugs preoperatively
* patients with severe chronic pain issues
* chronic atrial fibrillation
* patients who refuse to take part to the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No